Acceptable Risk in Biomedical Research: European Perspectives

By Sigmund Simonsen

Book Overview

1. Introduction

2. Method and material

3. Initial conceptual clarifications

4. Origins of the requirement of proportionality

5. The purpose of the requirement of proportionality

6. Introduction: Part II

7. Which risks, burdens and potential benefits are relevant?

8. How to estimate risks, burdens, and potential benefits

9. The requirement of proportionality - initial clarifications

10. Therapeutic research

11. Nontherapeutic research

12. Nontherapeutic research on "vulnerable" participants

13. Non-interference with necessary clinical interventions and the no harm rule

14. Especially on randomised clinical trials, including placebo controlled clinical trials

15. Acceptable Risks and Burdens to Others than the Participant

16. Later developments during the course of the research

17. Legal effects of the requirement of proportionality

18. Summary of results

19. Recommendations

20. Perspectives

21. Appendix

• Format: Paperback
• Language: English
• ISBN: 940079553X
• ISBN13: 9789400795532
• Release Date: February 2014
• Publisher: Springer
• Length: 296 Pages
• Weight: 0.92 lbs.
• Dimensions: 0.7" x 5.9" x 8.9"